Label: EXTREME PROTECT SPF 40 ALL SHADES- zinc oxide, titanium dioxide cream

  • NDC Code(s): 69219-108-01, 69219-108-02, 69219-108-03, 69219-108-11, view more
    69219-108-21, 69219-108-31
  • Packager: Science of Skincare, LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2023

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  • ACTIVE INGREDIENT

    Zinc Oxide: 15.3%

    Titanium Dioxide: 1.3%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Helps prevent sunburn.

    If used as directed with other sun protection measures(see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • WARNINGS

    For external use only.

  • DO NOT USE

    Do not use on damaged or broken skin

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Apply liberally 15 minutes before sun exposure.

    Reapply:

    After 40 minutes of swimming or sweating

    Immediately after towel drying

    At least every 2 hours

    Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:

    limit time in the sun, especially from 10am - 2pm.

    wear long-sleeve shirts, pants, hats, and sunglasses.

  • OTHER SAFETY INFORMATION

    Protect this product from excessive heat and direct sun.

  • QUESTIONS

    Call Customer Care at (888) 804 - 4447

  • INACTIVE INGREDIENT

    Water/Aqua/Eau, Zinc Oxide, C12-15 Alkyl Benzoate, Glycerin, Caprylic Capric Triglycerides, Tocopherol, Sorbitan Stearate, Panthenyl Triacetate, Titanium Dioxide, Pentylene Glycol, Ethyl Linoleate, Polyhydroxystearic Acid, Tribehenin, Polyurethane-62, Ethylhexylglycerin, Polyglyceryl-4 Isostearate, Hexyl Laurate, Cetyl PEG/PPG-10/1 Dimethicone, Butylene Glycol, Oleyl Alcohol, Xanthan Gum, Aluminum Stearate, Propylene Glycol, Asiaticoside, Asiatic Acid, Madecassic Acid, Alumina, Olea Europaea (Olive) Leaf Extract, Sorbitol/Sebacic Acid Copolymer Behenate, Magnesium Aluminum Silicate, Trideceth-6, Phenoxyethanol, Aloe Barbadensis Leaf Juice, Isostearic Acid, Disodium EDTA, Polyquaternium-7, +/- CI 77491, CI 77492, CI 77499 *May contain one or more of these ingredients

  • PRINCIPAL DISPLAY PANEL

    69219-108-21 5g 10 pack69219-108-01 Bronze 100g bottle69219-108-11 Beige Box69219-108-01 Beige 100g bottle69219-108-01 NT 100g bottle69219-108-02 5g single69219-108-11 NT Box69219-108-11 Bronze 100g box69219-108-0369219-108-31

  • INGREDIENTS AND APPEARANCE
    EXTREME PROTECT SPF 40  ALL SHADES
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69219-108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.3 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYURETHANE-34 (40 MPA, TENSILE STRENGTH OF FILM AT BREAK) (UNII: 77KA3O6NNF)  
    WATER (UNII: 059QF0KO0R)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    MADECASSIC ACID (UNII: M7O1N24J82)  
    DIMETHICONE 100 (UNII: RO266O364U)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)  
    ETHYL LINOLEATE (UNII: MJ2YTT4J8M)  
    ASIATICOSIDE (UNII: PKO39VY215)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ASIATIC ACID (UNII: 9PA5A687X5)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69219-108-111 in 1 BOX04/01/2021
    1NDC:69219-108-01100 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:69219-108-211 in 1 BAG03/02/2021
    2NDC:69219-108-025 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:69219-108-03240 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2021
    4NDC:69219-108-01100 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2021
    5NDC:69219-108-311 in 1 BOX03/01/2021
    5NDC:69219-108-03240 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/01/2021
    Labeler - Science of Skincare, LLC. (006251958)
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